Japanese healthcare company Daiichi Sankyo Co Ltd (TYO:4568) said on Thursday that the European Medicines Agency (EMA) has validated the Type II Variation marketing authorisation application for ENHERTU (trastuzumab deruxtecan) for adult patients with HER2 positive (IHC 3+) unresectable or metastatic solid tumours who have received prior treatment.

This validation marks the start of the EMA's scientific review process by the Committee for Medicinal Products for Human Use.

ENHERTU is a HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and jointly developed with biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN). The submission is based on three phase 2 trials -- DESTINY-PanTumor02, DESTINY-CRC02, and DESTINY-Lung01 -- in which ENHERTU showed clinically meaningful responses across multiple tumour types.

If approved, ENHERTU would become the first HER2-directed therapy and ADC to receive a tumour-agnostic indication in the European Union, offering a potential treatment option for patients with limited alternatives.